Compliance is mandatory for manufacturing facilities in the life sciences industry. It’s typically up to the quality team, made up of quality assurance and quality control, to oversee manufacturing operations to make certain that quality standards are being met and to ensure overall compliance with current good manufacturing practices, or cGMPs.
cGMPs require that each person involved in the manufacturing, processing, packing, or holding of drugs/medical device products, etc. have the proper education, training, and experience, or combination thereof, to successfully perform their assigned job duties. Accurate and up-to-date training records are required in addition to maintaining full job descriptions and current resumes. Also, training in cGMP and standard operating procedures, or SOPs, needs to be an ongoing initiative. Employees need to be made aware of and understand changes in any given procedure that affects their role within the organization.
It’s easy to understand how challenging this process is for life science manufacturers of all sizes. The good news is, validated learning management systems are robust compliance training solutions that can help to ease the complexity and burden of managing cGMP training and compliance. An LMS is more than a software solution; an LMS affords users the ability to manage the complete process of cGMP training.
Why Use a Validated LMS?
While there are many reasons why validated LMSs are an effective tool to manage cGMP training; there are several top reasons that make a very compelling case.
Reason #1 – Time Saving Automation
First and foremost, training programs can be developed and automatically assigned to individuals or groups of individuals based on their title, job role, location, or even their division to name but a few options. When an employee’s role changes, they can easily be assigned to their new designation and be automatically enrolled and notified about their new training program.
Reason #2 – Support of 21CFR Part 11 and Electronic Signature
SOPs are critically important in the life sciences industry. Training employees on regulated content in the form of SOPs mean that training recipients must acknowledge that they have read and understood the regulated content. When using software to distribute training, acknowledgment means capturing an employee’s electronic signature. Validated LMSs are designed specifically for regulated industries, and as such, should meet this unique compliance requirement.
Reason #3 – Real-time Reporting
Real-time reporting provides accurate insight of all cGMP training that is required and completed. Reports can be set-up to run automatically and be distributed by email, or they can be run on-demand. A validated LMS provides reporting that can be compiled with unique granularity. For example, a report can be run regarding completion rates per employee for a variety of SOPs or just one single document. Reports can be run for a single location or multiple locations; thus providing greater insight into possible training gaps that may impede compliance.
Managing cGMP training is an arduous task for life science companies of all sizes. Implementing a validated LMS can help your organization to identify and evaluate training needs, and automatically assign appropriate training programs to your employees company-wide. If you’d like to learn more about ePath Learning nGage, our validated LMS designed and developed for life science companies, contact us today.
Susan Distasio | eLearning Industry Crusader | ePath Learning, Inc.
About the Author: Susan Distasio is an eLearning Industry Crusader focused on advocating for advancement and change in the eLearning and professional development industry. An avid seeker of knowledge and continuous improvement, Susan is happy to share her research, observations, and thoughts regarding “all things related to learning and development.” When she’s not out on the learning crusade, Susan can be found with the wind in her hair riding her Harley or simply enjoying life with her husband, Steve, and her Siamese cat, Elvis, and with family and friends.